About this Course

This intensive two day course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485 and evaluate the effectiveness of the quality management system in their organization. Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.

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